FDA Registration for OTC Otic Drug Products
OTC otic products for earwax removal, and ear drying aid are regulated as OTC Monograph drugs by FDA — requiring establishment registration, NDC labeler code, and listing.
FDA Requirements for OTC Otic Drug Products
OTC otic drug products include earwax removal products (carbamide peroxide), and ear drying aid products (isopropyl alcohol).
All manufacturers of OTC otic products must register with FDA as drug establishments and list each product.
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing with Drug Facts labeling
- Annual renewal October 1–December 31
The FDA regulates OTC ear drops and solutions through “OTC Monograph M014: Topical Otic Drug Products for Over-the-Counter Human Use,” ensuring their safety and effectiveness as “earwax removal aid.” Or “ear drying aid.” This monograph dictates approved ingredients, labeling requirements, and proper use to keep your ears healthy.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Earwax removal aid active ingredient | |
| Carbamide peroxide 6.5 percent | M014.10 (Part 344) |
| Ear drying aid active ingredient | |
| Isopropyl alcohol 95 percent in an anhydrous glycerin 5 percent base | M014.12 (Part 344) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
OTC Otic Drug Products — FAQs
Are OTC ear products regulated as drugs?
What active ingredients are in OTC earwax removal products?
Ready to Register Your OTC Otic Products?
LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for otc otic products manufacturers worldwide.
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